democratic perspective on the federal budget, and later, a house subcommittee hearing on the national flood insurance program. [inaudible conversations] >> fda commissioner margaret hamburg testified on her agency's budget before the house appropriations subcommittee. the food and drug administration is asking for $1 billion more than 2010. the budget including additional food regulation and food safety initiatives. now a look at that hearing. it's about two hours and 15 minutes. >> the committee will come to order. we're happy today and pleased to have fda commissioner, dr. margaret hamburg and the commissioner for budget for fda, and there's a team behind you, i know that. we're looking forward to your testimony, although we have read

it and you submitted it, so you are welcome to just summarize it. i want to make a few notes of concern right now are the budget constraints, and you were exempted from the president's freeze, but you still have a 16% increase and in some of the areas with cuts they are extremely popular programs that will be put back in there by our friends in the other body like the natural product center like a $3.5 million cut. we're going to work with you in the house, this body would, but i don't know if the senate's going to go along with that. i don't know that you targeted it that way or not, but that was a concern of mine. i also wanted to comment on a couple other things that you have in your budget. you pointed out that the fda approves more drugs each year than all the other countries in the world combined and that you approve them faster than in

europement i think that's great. we're glad to hear it. the committee heard so many times over the years about slow fda drug approval on medical device approval, you are still up there and moving along which is good and positive, and so we're glad to see that. i'm interested in the fda track that allows the stake holders and witnesses to work with you and get quarterly progress reports on items of interest, and i think that's something very good. you've also have saved americans $140 billion a year in generic drugs which i think is of interest. as you know, i have some real questions on food safety in terms of what you actually could accomplish in terms of the model that was rushed through in december even though there was a lot hearings, but the last two

years were marked by the lack of bipartisan inclusion, and i would say that piece of legislation fell into that category as much as anything else. for example, the health care bill, so i think this congress is going to really keep a very close eye on that. you want, let's see, what is your number on that? is that, yeah, $382 million for that, and -- >> from? >> $218 million from discretionary, and keep in mind the money we're talking about for your entire budget in many respects is 100% borrowed. for every dollar we send now, 40 cents is borrowed. if you look at the money we spend interest on the national debt over $200 billion a year, and then put in retirement, health care, and national security, that's about all the

budget that's paid for which would be about 60%, and spending is a bipartisan problem. ifs something that both parties have -- it is something that both parties have their fingerprints all over. i was glad the president appointed a commission on it. we want to work with the president throughout this process, so the -- so much of the context right now as we look at various programs in the way that you and any other agency spends money is going to be in that prism of what is the best bang for the buck, what is our want, our need, what is the duplication, the gao report was pretty significant that came out underscoring a lot of duplication, and so those are some of the things that are on my mind, and i want to yield to the ranking member, mr. farr. >> thank you very much, mr. chairman for ranking, and thank

you chairman for being here and thank you for meeting with the leafy green marketing folks from my district. they were very, very impressed with the opportunity to talk to you. i know, and i think in your testimony, just one phrase that really struck me, and i think in light of the chairman's remarks, but by the way, that bill that passed, passed by a two-thirds vote. it wasn't a partisan, just a partisan vote. when you say the fda must do its job well because there's no other agency to fall back on, no one to backstop us, our role is unique, and fda must fill the unique role completely and responsibly, and i hope as we go through your budget that we can really help you do that role responsibly. there's too much at risk by

doing it kind of less than, you know, immediate mediocre way. i don't have a lot of comments to make other than i'm -- you're at a new turning point in american food safety history with the enaction of the bill, and the everyonation of the -- imp policemennation of the bill with a lot of eyes on you and they know you know a lot about safeguarding drugs and prescription drugs and other kinds of programs that fda, but i think it's more known on the medical side than the food safety side. it's a new era, but it's one that is critically important, and i'll just tell you, ms. chairperson, i saw it firsthand. we had this e. coli

contamination of spinach, and it was from my district. they asked anybody who had anything to do with spinach whether you drove it in the trucks, stored in the store or you had it in your home, you had to get rid of it. today, americans don't consume as much spinach as they did before that recall. people lost hundreds of millions of dollars, and they didn't get covered by insurance, so it is, it is extremely important that we and your agency be the good cop, but it also has to be smart ones so that we don't wipe out industries, and i appreciate coming today and i look forward to talking. >> thank you, mr. farr. we are joined by chairwoman

emerson. she's got another committee she's chairing. the floor is yours. >> okay, well thank you, chairman kingston. i appreciate this opportunity to present this year's fiscal year 2012 budget for the food and drug administration and discuss our priorities for the coming year. this hearing comes at a critical moment for our country and for our agency. we must be prepared to meet and capture the scientific challenges and global realities of our modern world, and the stakes for patients, consumers, our economy, and our global economic competitiveness have never been higher. our agency is charged with an extremely difficult task to promote and protect the health of the american people. this includes ensuring the safety, effectiveness, and wholesomeness of products that the american people rely on in

live saving ways, drugs, vaccines, food supply, and more, but it's also working proactively to foster science innovation to create tomorrow's new products. both roles deliver progress to the american people, and both roles impact our economy by encouraging consumer confidence, growing key industries, and creating jobs. thanks to the support of the subcommittee, we've been able to see tangible evidence of that impact over the past year. this year, we approved dozens of new drugs, vaccines for seasonal and pandemic flu, and medical devices for hearing and vision loss, severe as ma, and screenings. we have cutting edge tracing to track foodborne illness outbreaks, we can identify food problems in the first seven

months of operation, we contract with the other administrations to develop screening tests to ensure seafood safety and reopen the fisheries after the deepwater horizon oil spill. that's just a snapshot. fda is charged with a unique set of tasks, and was just mentioned, if we do not do our jobs and do it completely, there is in other agency or entity out there to backstop us. that is why i'm here to ask for your support. fiscal year 2012 budget for the fda. the proposed budget including 4.4 billion identifying four areas transforming food safety and nutrition, advancing medical countermeasures, protecting patients, and fostering regulatory science and innovation, and regulatory science facilities. compared to fiscal year 2010,

the fiscal year 2012 budget represents an increase of $1.1 billion, 382 million in authority, and that amount for user fees including $60 million for three new user fees fda is proposing. in addition, in an effort to contribute to deficit reduction, we will undertake nearly $30 million in contract and administrative savings across the agency. these four initiatives are critical to the mission in protecting the public health, and they represent important opportunities for our food and medical product industries to grow and strengthen the economy. in other words, they will provide great return on investment for products, for people, and most importantly, for the public health. let me explain how. first, transforming food safety and nutrition niche tie contains an increase of $326 million to

build a stronger more reliable food safety system to protect american consumers. we use these resources to aggressively implement the food safety modernization act that congress passed in december. this landmark legislation provides fda with the tools to establish a prevention focused food safety system placing the primary responsibility for prevention on the food producers and processers and leveraging the work for fda state and local partners. fda will make sure that american families have the information they need to make more healthful food choices through men knew and vending machine labeling. fda proposes 70 million. medical countermeasures include drugs, vaccines, diagnostic tests, and commitment needed to detect and respond to by logical, chemical and nuclear threats as well as infectious

disease threats. these all threaten the lives and safety of the american people. this investment helps accelerate the develop of countermeasures that we truly need to meet critical, national security in public health needs. third, protecting patients. this initiative for which we're proposing $123.6 million blshes -- establishes a pathway for live saving products. this offers substantial savings for the federal government and private health care. this initiative includes investments in scientific tools and partnerships to enhance the safety of increasingly complex drugs, medical deviolations, and bilogics. fourth, the fda regulatory science facilities initiative contains an increase of $47.8 million for the scientific capacity that supports all elements of fda's mission and enables us to truly streamline and modernize our regulatory

work by applying the best possible science, especially as we address more advanced therapies, complex devices, and emerging technologies. it will also allow fda to outfit and occupy the center for bilogics, drugs, life sciences, biocenters, and other complexes in shaping our role in response to pandemics, emergency diseases, and delivering bilogical threats. even in these difficult times, the fda's budget is essential to our ability to take meaningful science-based action on behalf of the american people. with these investments and your support, i'm confident that we can build on our past successes and better ensure our nation's health. thank you for the the font to testify, and i'm happy to answer any questions that you may have. >> thank you very much, dr. hamberg, and i want to

reiterate what mr. farr said about your ability. we appreciate the time you've given us to answer a lot of questions, and we have more today, but we priesht the on -- appreciate the ongoing dialogue, and i want to recognize the chairman of the full committee, chair rogers of kentucky. >> thank you, mr. chairman, and congratulations to your elevation to the chair. we think you'll be wonderful in that. >> thank you for your role in that, sir. [laughter] >> we think you'll do a great job, and already you are. my comments and questions on fda's role in regulating prescription drugs, particularly opo and narcotics. undoubtedly these drugs make a world of difference for patients suffering from cancer or other termly ill diseases that cause chronic pain, but the abuse and diversion of these drugs is the country's leading drug problem. in the last decade, there's been

a 400% increase in those reporting abuse of pain pills, and in kentucky, we're losing almost three people a day to prescription drug overdosing. my people and communities around the country are doing their part in recognizing that we'll need a multifaceted approach to knock out abuse. law enforcement, treatment programs, and education will all be crucial, but regulatory agencies need to do their part. fda, of course, has an all-together important role in this, and in 1995, fda approved what you thought was the next miracle drug for cancer patients. a controlled release pain reliever, oxykotin.

it's cries as -- twice as potent. they tried to sell as much of their drug as possible. they chased primary care doctors and doctors in rural areas who may not have been as adequately trained in pain management as perhaps others. they underplayed the drugs addictive tendencies, and within five years, oxy was the most prescribed brand name prescription for taking care of moderate pain. they were raking in the dough, and that's about the time the people in my district started showing up in emergency rooms or in the morgue. in 2001, frank wolf and i testified before the faa asking that this powerful drug only be made available for the treatment

of se streer pain -- severe pain where it can have the most positive impact on patient comfort and care. our pleas fell on deaf ears, and the rule continued to be you can have moderate pain. you have a soar toe? here, have some oxy. it's terribly addicting and hard to shake. purdue was sued in criminal court, $600 million for its unscrupulous marketing practices and even faced criminal charges. they had to reformulate the drug, and you recently approved the new version. they still sold $3 billion worth of the drug last year, and its generics are not far behind. i'll let you decide if justice has been truly served, so what can be done?

there's a thing called a flamingo road where there are more pill mill crooks operating clinics in florida than mcdonalds drive through. people from other parts of the country, especially in my district, my state are hired by drug pushers to get on the bus and go to florida with them. they all go through the pain clinics, come back with a barrel full of oxy and other prescription medicines where they are sold for 10, 15, 20 times of what they paid for them, and people are dying. they are too easily obtained. fad has to be a -- fda has to be a partner in this fight. despite recent years in labeling

requirements, partners with federal agencies, and increased communications with physicians, and patients, still they are underinformed about the risks associate the -- with these products. fda has to be fully aware of the implications of these drugs before they go to market which is why congress instituted the rems requirement for extended release pain drugs in 2007, and these to tent drugs must be more carefully classified. we simply can't keep handing these responsibilities over to profit-driven drug companies. it's reckless. it's irresponsible, and it's why prescription drug overdoses are killing more americans now than car wrecks. think of that. that's why congresswoman from

california and i filed a bill called stop oxy abuse act which would moderate and change the severe qualifications to be changed of oxy to just severe, severe pain only. i would like your reaction to that. i'm going to leave several questions for the record, mr. chairman, if that would be okay. >> without objection. >> bucannan congressman has a bill to reclassify all drugs, vicodin and others and scheduled two drugs which are more difficult to prescribe and obtain. would this cut back on abuse? i wanted to leave that for the record. number two, congress requires rems to ensure the benefits of a drug outweigh the potential

risk. i heard real concerns that fda is allowing the drug companies allowing pain medication to develop a one-size fits all rems. considering that each medication is different and poses unique risks to patients and the public, how will this one-size fits all approach encourage innovation and risk management? then, finally, what is fda doing to incentivize and speed up the development of more tampered resistant or abuse resistant formulations of these drugs? dr. hamberg, i appreciate you being here today and answering the questions and presenting your budget request, and i am very focused on in my own way on the drug abuse problem that is afflicting the country and killing young people even as we

speak. today in kentucky, three people will die from dug overdoses that could have been prevented, and i think the fda needs to join the fight. thank you, mr. chairman. >> thank you. dr. hamberg? >> well, thank you very much, congressman rogers for your very powerful statement about the serious problem our nation faces with respect to the abuse of prescription drugs and as you point out, it's one that takes a devastating toll on individuals, families, on communities, on our nation, and it's impact is very, very severe and far reaches, and successful, meaningful, and enduring solutions to it as you point out require two partnerships because there are many players that need to play a role. fda has a critical role, and we care deeply about it, and i'm personally very committed to

helping lead the agency to engage more deeply on these issues with our counterparts in government and in other sectors, and to look very carefully at where we have responsibilities and where our activities and policies can make a difference. we are, as you said, looking very carefully at how we can more affectively use the authorities and tools that we have in terms of warnings and indications for use. we also have mounted a major initiative around the safe use of prescription drugs and its critically important in the area that you focused on in your comments is a key component of what we want to accomplish. there also is an administration wide effort focused on this, and that's very key to engage law enforcement, to engage educators, to engage the dea who

would be involved in making the decision in terms of reclassification. >> can u help you spell brower county florida? nine out of ten prescription of oxy in the country are coming from florida. nine out of ten. it's pill-mill heaven. there are thousands of them there, and i've asked the attorney general to send enforcement to the county to help us stamp out of problem. we asked the governmental governor of the state for drug prescription monitoring program which he refused, although 40 states have the system in place. where do i turn? can you change the rules by which these medicines are prescribes for just severe pain? why not do that? >> well, i think, you know, these are important issues and, you know, as you pointed out,

they do involve many different agencies coming together. we approve -- we review and approve medical products for a certain indicated use, and that can certainly be a part of our considerations. there are also very important activities that have to do with the oversight of the providers and how they are doing their prescriptions. the training of providers and enforcement activities, so i think -- >> it's simple. it's really simple. this drug, oxy was built, designed, constructed for severe pain; right? it's a 12-hour release pill. it's a wonderful drug for those in severe pain and those with terminal cancer and others, but it's so easily dispensed and so easily taken. it's such a wonderful drug to be

abused that young people especially are crushing the 12-hour release into an instant release, and you can imagine the pleasure it gives, and it's irresistible, but it's killing people. can't you change that formula by which they are prescribed? simply leave out moderate? >> in how we are approaching the warning labels, the indications for use, you know, we are very mindful of those concerns. you raised another important point i want to underscore which is how can we bring better science to bear to make products that are safer and less subject to abuse and opportunities for innovation in this area. we need to go forward today to address the current problem and making sure that we are pursuing those avenues as well. i'm hardened to hear about your work in this area and the bill

you're proposing. we're eager to work with you. sounds like i should make a visit down to florida and learn more about that. >> absolutely. i'll pay your way. >> i don't know that that would be allowed. [laughter] >> chairman, can i ask you just to yield for a second? i agree with you. i'm getting off a broken arm, and the first drugs they threw at me were an oxy, and while i was in pain and a lot of pain, i wasn't in severe pain, so i was afraid to take the drug because i know the effects are really pretty dramatic, but every single time i would go for a follow-up, they would ask if i needed more? i just took four advil and that did the trick for me. they were throwing this stuff at me. i flushed it down the toilet, and i'm not sure you're supposed

too that, but anyway -- [laughter] >> we don't have to remove that from the record. [laughter] >> it's troubling to me who just recently six weeks ago dealt with the same problem. it's an incredibly important issue with huge ramifications. >> we are eager to work with you, you know, we are involved in activities in this domain. there is more that we can do. i think the partnership in terms of administration-wide effort is going to make a real contribution as well, but i'd be eager to, you know, sit down with you, to visit. the flamingo road did you call it? also, to, you know, really lay out in more detail where we as the fda can make a difference.

>> i ask you that today and that's why we're here to answer the question. if you strike out the word moderate and only prescribe it for severe pain, we can then prosecute people who are unscrupulously making zillions of dollars under the guys that prescribe it for moderate pain. i mean, this is done every second of the day, but if you only allowed them to prescribe for severe pain, we can then prosecute and go after the unscrupulous doctors and pain clinics that are killing our people. it's pretty simple. >> well, i think, you know, as you point out, targeting for appropriate use is absolutely key, and we are trying to achieve that through what we're doing in the rems arena and strengthening those. is hard, i don't think you'd

be satisfied with the results by simply addressing that change in the indicator. >> it is a start. >> it is the broader abuse that is happening that i think is causing this serious national problem. it is how you define moderate and severe, i think we need to have a concerted effort that is targeted at many levels to address the problem, that is cross cutting, that involves what are the kinds of drugs available, how are they prescribed, what are the oversight and restrictions on the use and abuse of those drugs, and how that is enforced. >> mr. chairman, i appreciate the indulgence with the time. that is what we have to do in our district. the state newspaper came out with a story that ran six

weeks, screaming headlines that that area was the pain prescription capital of america. which prompted me to start an organization called the night. recall that unite. we have 2600 undercover agents who do nothing but arrest people selling drugs. they have put in jail 3700 pusher selling these drugs from the flamingo road the source. we have kids in hospitals every day. kids dying every day in emergency rooms. we have built treatment centers. i go to graduations for people who have kicked these things and here wonderful tales. it is a pervasive, deep, widespread problem, killing more people than automobiles, yet you

sit there and say we will not talk about changing the prescription rules for this killer drug. and i won't rest until we see an answer, ma'am. >> i am happy to continue to examine these questions and go back with our expert team. my point is if we really want to make a meaningful and enduring difference, it is a different problem than simply changing the indication. whether it is an indication for severe or moderate, to prescribe. this ultimately making the decision -- the prescribedr is ultimately making the decision, and i am not confidence that it will change the behavior on flamingo road. >> it is a chance to prosecute people who are prescribing the medicine for other than severe

pain. what could stop the problem at the source. you are in charge of the steering wheel. i expect some movement on this issue. if you don't do it, we will do it for you. i cannot be much more plane than that. i don't mean to be blunt, but this is beyond a minor issue. this is a killer in my district, killing my constituents, and all around the country, and you could make a difference. >> i am eager to make a difference. i appreciate the severity of the problem and its huge ramifications on people. i feel we have a critical role to play it and we will engage fully. it to be successful, it needs to be a broader partnership, and i am committed to engaging in those partnerships to make

measurable progress in this domain. >> thank you. >> i share your concern, and i think you also have to go upstream and look at the manufacturers and sales. my cousin is a doctor and he says most of the information they get about drugs is from the sales person who tells them you all to use this for this and that. if there is that much supply going to doctor's offices, there has to be something to the with the message is given to doctors. i think we need to look at that as well. i think this conversation really goes to the point of how important your agency it is, the food and drug administration, and how difficult it will be to manage these critical issues if congress cuts your budget. a couple things i'd like to see if we could get better bang for the buck. one is in the area of medical

countermeasures. as you know, medical countermeasures initiative was framed in the course of 2000, based on the fact that we put a lot of money into the flu pandemic. i think mr. rogers played a major role in pointing out that was real serious. what happened last year was hhs shifted money from their account to your account to cover the new medical countermeasures initiative, but you need, as i understand it, language to expand to other types of copter measures that could work on. the idea that if we have the infrastructure to do that, we could look at countermeasures for other emergencies that might come from biological weapons or

other things that could break out, contamination that could break out, pathogens, influenza. that we have to isolate this work to one countermeasure, and i wonder if he could speak to how important that is to keep the money, how important it is to get the language that you need to be able to have those other countermeasures. >> thank you, this is a very important area for the health and security of our nation. we face a set of serious biological threats, such as pandemic flu or something like or an as yet unrealized. it. we're also increasingly foldable to intentional -- we are also

increasingly vulnerable to potential release of biological terrorism and the health of individual impact would be enormous. also, the huge dislocation to our society, the disruption in life as we know it, the impact on the economy, public trust and confidence in government and critical institutions, international security at its corporate that -- at its core. we want to provide medical countermeasures necessary to rapidly detect and respond to an emerging threat and to treat and contained a threat should it occur. anyway, it is a form of deterrence to be better prepared and to also limit the damage that can occur. >> my understanding is you have the money to do the work, you just don't have the authority to look at these other

countermeasures? >> exactly right, the secretary of health and human services, kathleen sebelius, began a new countermeasure last summer, and the fda was given resources to begin imports of work from the moneys that had originally been appropriated for pandemic response. >> we need to put that one which in our legislation, but it did not get into latest version. >> right, to be able to expand these activities to address not just pandemic threats but continuing biological threats before us, we need additional language. it is a no cost proposal that would allow for the use against this broader set of very important potentially devastating biological threats. we would be very appreciative if you could look at that. i think would make a huge difference to our ability to

move forward in critical ways. there are important gaps in key areas. we don't have a treatment for acute radiation sickness, such as what would occur after a terrorist attack using a radiological device. we don't have antiviral drugs to treat a number of critical potential microbial threats. we don't have the diagnostics that we need to rapidly detect and diagnose the emerging problems to treat them appropriately. >> yes or no, can we assume if these are not provided in the budget amendment that there is very little or no chance that he could find these -- you could fund these activities within the appropriation in hr-1? >> that is the case. this is a program where we are building new capacity.

these targeted additional dollars are essential in fulfilling the mission of ensuring we have the medical countermeasures that we need. in the present fiscal year we are also asking for money is to continue those programs that we are beginning to put in place now. it will make a difference. interestingly, as this broader initiative was being developed, one of the things that emerged was the role of the fda was absolutely crucial to the success, but it involves all the components of government, but the fda's role in being able to review and approve for safety and effectiveness these medical countermeasures was the linchpin of success.

we very much appreciate you taking a serious look at this and helping to support efforts that will make such a difference to our nation and our security. >> thank you. >> the gentleman's time has expired. >> thank you for being here in the job you do. i know you share my concern about counterfeit drugs entering the united states, in the supply chain, whether from within the that the states or abroad, yet the potential for this corruption of the system and a reward for doing so is growing. it is really interesting and frightening to see how sophisticated some of the methods that counterfeiters are using. last year in connecticut, $76 million of drugs were stolen. a year before, $5 million of drugs were stolen in virginia.

this illustrates the fact that this is a problem bigger than mere counterfeiting. the stolen drugs that are removed from the supply chain or simply lost, before we appearing, and that could possibly be here and could also appear as treatment for us. last year the committee included language asking fda to examine methods and technologies by which these drugs could be tracked within supply chain from manufacturer to the patient, with a minimum of cost to either party or anyone in between. i wanted to follow-up on that request for the new standard, just to gauge your opinion on the possible role for the fta, as well as to ask you -- for the fda, as well as to ask you if you see a national system safe and affordable? >> you raise a critically

important issue. increasingly in our globalized world, we need to be thinking about drugs coming from many parts of the world and complex supply chains that the drugs go through, with webs of producers, manufacturers, suppliers, we packagers, exporters, importers, and all along the way there is the opportunity for the potential introduction of problems, sometimes unintentional, and sadly we know deliberate. counterfeiting is an increasingly significant criminal enterprise. because the penalties for trafficking in counterfeit drugs are much less than in illegal drugs, there is concern that organized crime is increasingly entering this space as well. we know the impact on people are huge. he mentioned drug diversion. there was a recent case where insulin was stolen, disappeared

from the marketplace, and then reappeared, but the only way we found that it reappeared as we started getting reports that diabetic patients were taking insulin, they were depending on this drug for a very serious medical problem, and it was having no impact. we determined that this insulin was from the stolen. the ability to track and trace is essential. we would very much welcome the chance to work with congress, to look at the opportunities for new legislation. i know there is a bill that has been introduced that would give additional authorities to fda to help us secure the safety of the supply chain and address these global challenges. >> california has a standard

which is set to be implemented in 2015, and even with the best possible state model, the think a state-by-state approach is more effective, or is it more sufficient to have one single, national approach to the problem? >> i think this is a problem that crosses state borders and crosses international borders, and the goal of the standards are harmonized is important. it is important government and industry, as they think about how that would implement this and the cost of implementation. >> can you estimate the pervasiveness of the counter that problem? >> we need better data. it is a worldwide problem. we don't fully know the nature

and scope of the counterfeiting. in some parts of the developing world, as much as between 30%- 50% of the drugs on the market place for serious diseases are a factor for it. in the united states, we have a much more closed system, and the fda is working every day to ensure that the drug supply is safe and when you go to your pharmacy, what you get is what is purported to be. but we know the problem is real here as well, and that we need to be proactive and aggressive and we need to be very cognizant of the fact that as the world becomes more globalized and more drugs are coming from being manufactured overseas -- >> the gentlewoman's time has expired. >> i look forward to working with you, and thank you for

allowing me to go early. >> thank you. >> thank you, mr. chairman. thank you, dr. hamburg, for being here. i would like to focus on the drug avastin. as i understand it, the fda granted accelerated approval for avastin for the treatment of breast cancer in 2008, and now the fda is looking at withdrawing that approval. it is my understanding correct? >> there is an expedited approval mechanism that is enabled on the basis of fairly early data on the drug's safety and effectiveness to grant a modified form of approval, expedited approval, and then require additional studies to be done, and then a decision is

based on the broader set of data whether the drug should get full formal approval. in this case, after additional studies were done and an advisory committee of experts was brought in to review the data, a decision was made not to give avastin full approval. i should say that we are in the process of working within the legal framework of this approval, regulatory mechanism -- we have granted the company that makes avastin a hearing, a public hearing with the fda, making their case. because we are in the middle of that process, i actually cannot comment any more deeply about this drug. >> you cannot tell me -- you

approved it then, and you are putting it on hold now. you cannot tell me, what is the problem? >> the additional data that was collected and examined both by the fda scientists and reviewed by this panel of outside experts did not support the full approval for the indication. however, as i said, because we are in the middle of the legal process and i ultimately will be reviewing all of the data, under this system of public hearings, and a subsequent decision, i am really not at liberty to have a full discussion of the matter ough.

>> it is my understanding that this drug does not cure breast cancer, but it does prolong a woman's life. the initial indications might be as long as five, seven months, and now it may only be three, five months. because it did not do what we originally thought. >> if i could, because i am in a difficult legal situation, because there is a legal process with a hearing, and ultimately i need to be the final decision maker, and so i need to be at a distance from this. if i could asked our centre director to speak to these issues? >> think. i am janet woodcock, the head of the drug center. avastin is approved for multiple

cancers. the regional trial showed an effect on what is called progression-free survival, which does not have anything to do with living longer. it has to do with how long before your x-rays show the disease has progressed. the subsequent trial did not show the same effect. it was a much smaller effect on how long it took the x-rays to worsen. there is not a claim that avastin improves revisal in this setting of life. the dispute was over the length of time it takes to progress want to have the disease. it does that make sense? >> i may have said it wrong. initially, it was thought to be five-seven months. it since it is shorter, you are saying let's pull it? >> the initial was a surrogate.

that is why it is called accelerated approval. progression-free survival was generally in this case that your x-rays don't get worse. it is considered a surrogate for having some actual benefit to people, say, not developing pain or fractures, or actually living longer. the subsequent trial showed a smaller effect on x-rays not getting worse, which are advisers and ecologists did not feel it -- which are advisers and cancer doctors did not feel would help reduce pain, reduce progression, or longer life. >> thank you very much, mr. chairman. i would like to take a different tact and began with the statement, the obvious assertion that america will experience economic recovery when people get jobs and go back to work.

i follow with interest to continue outsourcing of u.s. jobs, including by pharmaceutical companies, making medicines and devices everyplace else in the world and moving jobs outside of our country. every day i asked myself, how could we make goods in america again so people can go back to work? there are some who believe that we can fix what is wrong with our economy not by creating jobs in our country but by simply cutting back on public health and safety, as is evidenced in hr-1, the continuing resolution offered by the majority party. cuts inspectors for food safety. i want to turn to questions i have asked in the past regarding tracking what is going on with the manufacturing of heparin, the cost of that

through public sector in medicare and medicaid, and go back to march, 2008 when the new york times had an article that said the food and drug administration had linked it to 19 deaths and hundreds of severe allergic reactions, though the agency was continuing to investigate. those deaths and a large degree actions were due to components that and it up in heparin, that ended up getting into it from china. i was wondering if you completed the investigation and how many people may have died from those of imported components? that is my first question. have you finished a report, is there additional data? then i want to ask this -- you have kindly submitted for the record from previous question i have done questions that i have asked regarding heparin./

heparin is actually made from the intestines. i represent a lot of hog farmers, so i am interested why we would go to china for heparin. the test teens -- the intestines are ground up, extracted, and they eventually get the protein. i don't know if it is a blood thinner -- >> blood thinner. it keeps you from getting blood clots. b>> thank you. what is interesting about what you wrote in answer to my question, he said the fda had approved applications to market heparin, but it does not say anything about manufacturing. it is not clear where the ingredients are made. i want to know for the three or four companies that are listed that are supposedly marketing

it, how many of the ingredients come from the united states? i will push you a little on this, maybe not today, but in further questions. i'm also going to ask about damages. our government and the american people were not able to recover damages from the deaths because of contaminated imports? and where would i get how much money is being made by these pharmaceutical firms in marketing these products compared with one it takes them to manufacture? can you get at that, or where do i have to go for those numbers? >> you have asked a string of questions imbedded in the one important issue of heparin, and some of that we may have to get

back to you one. the experience with contaminated heparin was very serious. it was an eye opener to the fda and the pharmaceutical industry into our nation more broadly about the fact that we need to be paying attention to the fact that the supply chain for many products in this nation is complex and global. as you point out, the precursor for heparin that is used in the u.s. and manufactured by u.s. manufacturers, but much of the precursor comes from china, which i think has more pigs than any place in the world. >> we have a lot in ohio, too, and we would like to compete in this market. >> but it cost, as you pointed out, serious allergic reactions and many deaths. >> do we know how many deaths

yet? >> in terms of the documented deaths, people do. why- nine >> is it impossible to know? >> because sometimes the providers don't make the association between the death of a patient and the contaminated heparin. they often have complex medical illnesses, and when a person expires, the connection was not necessarily made that it was because of the heparin. as with all the investigation and we began to understand the and between the hepaeriarin fatalities, we know that it took a serious toll. in response, we have put in place and number of protective

measures, a new screening tests and safety systems, also working with regulatory authorities in china on this and working with the private sector so that we have safeguards that this >> that this kind of event with heparin will not happen again but there's vulnerabilities that we need to work on. i think my time is up in responding to you about but we're happy to respond -- >> i want to thank the chairman for his generosity. to get to the bottom of this is extraordinarily difficult. we're going to keep digging in this one. we're all struggling to try to find the money to balance the budget. and if you look at the amount of money that our government pays through the medicare and medicaid accounts for heparin for a drug that's off-pat for a -- for material that's off-pat

that's unbelievable so this has many legs to it. and i thank you very much and we will have many follow-up questions on heparin. thank you. >> as you can dr. hamburg, members of this committee are passionate about these issues and do appreciate your time. i want to visit the discussions you and i have had about food safety and the food modernization act. using the cdc numbers which you have and i agree with you 3,000 deaths a year is horrible. we need to do something about it, 48 million illnesses but where i have an issue taking the emotion out of it and i know we have talked about this. but that 3,000 people dying a you know is down 40% from last year again it's too high. we need to keep working. but it's down 40% from the cdc numbers. 48 million food-borne illnesses

a year is down 37% a decrease of 28 million from last year. still too high. but in a country of 311 million people, eating three mills a day, 365 days a year, we are consuming 340 billion meals a year and if you divide the data into the 48 million we still have a food supply that is 99.99% safe. where's my math falling on that? >> well, i think that the key numbers are that, you know, we know that about 1 in 6 people get sick every year from food-borne illness >> well, let me interrupt a minute. key numbers come from the cdc, and those are the numbers i've used. those are the numbers i want to stay with. >> that's consistent with their numbers. i mean, i think as you point

out, you know, we're seeing preventible deaths. we're seeing even more preventible illness. that is associated with a set of other preventible costs caused to the health care system, costs to economic productivity. >> but you agree with my math that it is 99.999% safe? >> i would have to sit down and follow your math, but we have one of the safest food supplies in the world. there's no doubt about it. and we should be proud of that and we should be sure that it's maintained that way. >> well, the concern that i have is are we targeting the 3,000 smartly and efficiently and effectively because if we move that number from 99.999% to 100%, which you and i everybody on this committee would certainly want to do, are we going to get there -- are we going to get that last percentage -- are we going to

get it where we -- with this bill? and i'll tell you why i have concerns about that. on 60% of the illnesses come from neurovirus and there's nothing that attacks it. in your testimony you mentioned that you have permitted a test for it last year but that's the only mention of norvirus and the cdc on march 4 said that appropriate hand hygiene is the single most important method to prevent norro virus and transmission and any viewers' voice on our hands is best accomplished through washing -- hand washing with water and plain antiseptic soap and we're talking about 17 and 18,000 employees and that is not addressed in here. 60% of the illnesses.

the second highest is salmonella. of course, i come from poultry country. now, before the food modernization act, fda did finalize a salmonella egg rule july of last year. and that's something like 79,000 illnesses or 30 deaths. but that it could be avoided with this new food safety requirement which you put in to effect july of last year. so, you know, i don't want to say that box is checked and i'm going to let you respond to it. the third highest is and you don't mention that in your budget. and it would appear to me that those are the three things that we need to target in order to close that percentage and, you

know, in the tight budgetary time i think that would be a lot smarter approach. >> you know, mr. chairman, i understand your concerns and i think that, you know, we all recognize that we have a food safety -- a food supply that is generally very safe. i think no one can argue, though, that we are experiencing a set of preventible outbreaks due to a range of microbes, some which cause more severe disease, some which are more prevalent. but it's a range of concerns and it's a changing panoply of concerns. salmonella wasn't thought to be such a major concern in products like peanuts. today we know that it's a very different situation. >> but what you say today, this is only in july that we have the new salmonella rule. of >> that was for egg but if i

could just -- i think what we need -- >> and i want to point out that the peanut problem which occurred in mr. bishop's district and he and i are on a same page and that was a criminal act of safety but much is a criminal act. >> we are seeing salmonella in those kinds of products. what i'm saying is -- you know, we can't only have a food safety system that addresses problems that have happened. we need a system as the food safety modernization act calls for that really puts an emphasis on preventing the introduction of contamination of any kind. and that is what i think is the huge opportunity here is to move towards a system that is really based on prevention so that we can prevent those unnecessary deaths. we can prevent the unnecessary costs to the health care system. we can prevent the unnecessary cost to industry. and to our economy more broadly.

we also in a globalized economy have a whole set of additional threats to the safety of our food supply that we need to be very mindful and prepare for. so we are trying to create a food safety system for the 21st century and beyond, and i think that we have a responsibility to take that very seriously. congress has given us the mandate to do so and, you know, and i'm very excited about the opportunities to keep moving the dial so that our food supply is as safe as it can be. >> my time has expired. >> thank you, mr. chairman. i wish we had a whole week of this panel because, in essence, we're talking about -- as dr. hamburg indicated in her testimony and because i don't think we ever had a head of the agency that has such a tremendous academic and medical background as you've had. and i'm just fully appreciative that you took this job.

you are -- you are the -- you are the first responder to any problem that happens in illness in america, no matter where it comes from. your agency is the one that has to stop it, find cures for it. and i think that we sometimes in this big budget slashing that we have to do here in congress, i wish it wasn't so much slashing as to use a medical term since you're a doctor is that we could find -- you know, do just microscopic surgery is what we really need. and surgery has to be done that way. it has to be very smart. and very effective. but we don't do it that way. and so i'm almost thinking that we ought to have a week of discussing what would be a week without the fda?

everything would come to a grinding halt in this country. because indeed you're responsible for articles used in food or drink, for not only mankind but for animals. things that we don't think about that are regulated like chewing gum. put a lot of that in your mouth. dietary supplements and dietary ingredients, infant formula, beverages even including alcoholic beverages. fruits and vegetables, fish and seafood dairy products and shell eggs. raw agricultural commodities which we grow in our area like lettuce and carrots and things like that. canned and frozen foods, live food animals, bakery goods, snack food, candy, chewing gum, animal feed. i mean, just a whole bunch of things. the food safety modernization

act which did pass by broad bipartisan support and in that -- and the chairman has already pointed out the number of deaths that occur in this country. the president requested $183 million for implementation of food safety law. my question is what would happen if that money was not inappropriate? seven congress did not give you the president's request of the 183 million to take those tougher responsibilities that we have mandated upon you? >> well, we are very committed to moving forward with the implementation of the food safety modernization act. and we are beginning to implement some of the very many new mandates and requirements contained in that bill. we will be able to make significant progress in key areas.

we will continue to be able to put forward the -- >> you don't get the money is the question? >> yeah. if we don't get the money, we will not be able to fulfill all the requirements of the act without a doubt. we will importantly not be able to fulfill the very ambitious inspections, mandate domestically and internationally which means we won't be able to get that hands-on look -- >> let me follow up just on the inspections because, you know, a lot of the product that we eat, particularly you think in the wintertime we eat a lot of fresh vegetables, a lot of those do come from mexico. we have to inspect them coming from the border. we also sell a lot of food grown in the united states. california gross 80% of all the almond feed in the entire world. and that's more almonds than all the people in the united states eat so we have to export those. those require inspections in order to be purchased by foreign countries. if our side of the inspection

falls down, we don't live up to our regulations, what does that do to the movement of food supply? >> well -- >> particularly with fresh fruits and vegetables that don't have any resale? >> about 40% of the fresh fruit and produce that we do eat in this country come from outside our borders so fda has a very serious responsibility to be able to assure the safety of those products and it means not just inspections at the border, which are hard to do. and very costly and time intensive but actually going out to where the products are coming from and trying to assure the safety of that supply chain. as you point out, you know, we also need to have confidence in a robust food safety system in order to support our exports of foods to other parts of the world. and when there's an outbreak, a preventible food borne outbreak, it can have a very devastating impact on the health of that sector of the food industry in

terms of sales domestically as you well know and also the ability to do exports. and if we can't do the inspections that we need to do, we will not be able to assure the american people that the food that they're putting on their plates and serving their families is safe and wholesome. >> and if you don't do the inspections, food doesn't move? >> food doesn't poof. -- move. >> members of the committee, we're expected in a vote maybe in the next 5 or 10 minutes and it's going to be two votes by 10 minutes of a recommit. what i would like is to do if it's okay with the committee, i would like to vote, come back, give the gavel to mr. nonely and then and we can maximize our time with dr. hamburg if that's okay. [inaudible] >> okay. one vote and so -- yeah, there'll be plenty of time. we'll be able to get this done. aren't you glad.

[laughter] >> mr. nunley. >> thank you, mr. chairman. i want to continue the questions about the food safety modernization act. you may have already stated it but let's look at it specifically. how much is requested in your 2012 budget for implementation of the food safety modernization act? >> how much is requested? >> yes. >> it's 183 million. >> $183 million. how will we know this time next year? if that $183 million has achieved the results that were intended by the bill's passage? what specific methods of monitoring and tracking will we have this time next year? >> well, we do intend, of course, to track very carefully our performance as we move

towards implementation of the food safety modernization act. and i think we recognize that there are a number of key areas that we have to make significant progress moving forward. we need to begin to put in place the preventive risk-based approach working with industry and with farmers and producers to make sure that we have identified and agreed on where the points of vulnerability and what should be done to shore them up. we need to continue to expand our inspections, of course, it takes a number of years before an inspector is trained and able to go out in the field and really perform at full capacity. so some of the impacts of dollars today won't be seen for a few years down the road. we will be strengthening our import safety activities to make sure that we both expand our inspections overseas but also work more closely with

regulatory authorities and with industry to assure that foods are being produced, manufactured according to our standards. we will be working closely with state and local partners and that's a very important additional component of the food safety modernization act that we haven't had a chance to talk about yet. very much it's a partnership. we will be working with states and localities in terms of helping them to strengthen their capacities and the contribution that they make to monitoring the safety of the food supply and responding to when they occur. -- outbreaks when they occur. there will be very clear activities underway. we will be promulgating a produce safety rule. we'll be putting in place other guidances and taking other

actions concretely in terms of what's required for implementation. but i do want to caution that much of the transformation that needs to happen and the building up of program will take time. it's not a one-year activity. and it needs to be a sustained activity as well. >> will the gentleman yield? >> sure. >> you're talking about 17,000 new employees and about $1.4 billion in a 10-year period; correct? that's what the findings are? is that correct? >> is it -- that number of new employees seems accurate. >> in the 10-year period of time that's what was -- that's what was -- everyone was saying last year. in congress and the debate. >> yeah. if that was -- i don't know how many ftes --

>> it's a cbo estimate. you're talking massive bureaucracy and the times for every dollar we spend, 40 cents is borrowed in the background of a 99.99% safety rate in food. >> your response was on activities. and i'm new here but my observation is that when government measures and monitors, it measures activities. not results. and so i guess the follow-up question is not how are we going to measure your activities? but how are we going to know in 2012, is this $183 million achieved any results. >> well, as we put in place this program, we're asking for this money in fiscal 2012. and as i said you won't see the results that same fiscal year in

all cases but in terms of impacts on people and that, of course, is what really matters, you know, we will see if we do this right fewer outbreaks of food borne disease. we'll see fewer people sickened by the food they eat. we will see a system that can better assure that not just food produced in this country but food produced overseas coming into this country will -- that that imported food will be produced according to our same standards and will again be as safe and wholesome as we can assure. >> i think my time has expired and i'll get back -- >> thank you, mr. chairman. i'll just ask to you submit, dr. hamburg, if you could in the past year how many drugs have been approved in the arena of serious mental illness?

every year i ask for that. i'm always interested. it's very slow in coming. i'm wondering if you've been able to expedite the platform for these very, very debilitating illnesses that affect millions of people across our country. but i want to go back to the heparin issue. first, i want to ask your opinion as a doctor how complex a medical product do you believe heparin is versus other products that you regulate? is it at the top level of complexity? is it medium? is it simply? -- simple. >> it's a very complex mod chew -- molecule, there's no doubt about it. >> do you know where all tingres of heparin are produced? >> heparin is produced with one of the supply chains i was describing that has multiple inputs, and there's precursor materials it comes from many

different sites. and then -- >> and are you at those sites? is fda at those sites? >> we don't have the resources to be at every site where every component of a product that is in an fda-approved drug is made. we try very hard to use our resources wisely, and we are at manufacturing sites to inspect them before we approve a new drug. but that's where the drug itself is manufactured. >> not where the ingredients come from? >> you know, we work with companies -- >> i'll tell -- ma'am, i'll tell you i'm a little uncomfortable with what you're saying to me. if i bake a cake at home and i look at where the ingredients are from, for example, i know where they're from or at least i think i do by reading the label. but for these drugs and medical products like heparin it seems like there's a lot more being

offshored -- how do we know under what conditions those pigs actually live? >> and one of the reasons why we have really developed a much broader international program is so we can get a better handle on these kinds of issues. we now have offices in china, for example, to enable us to be on the ground working with manufacturers, working with regulatory authorities there. >> i really wish i could get you on the ground in ohio so we could provide them with real competition. as i look at some of the answers that were provided to past questioning it looks like illinois has really got this thing wrapped up and maybe there's not as much competition as we think 'cause we're looking at three companies here all in illinois, shamberg, illinois, deerfield illinois, lake forest illinois. three companies, i wonder if they have connecting doors? i don't know i'll have to take a ride over to illinois and take a look. but according to information that you -- you know, i'm really -- i'm going to become an expert in heparin.

if americans died, we ought to know why. and we ought to really go back and understand that production chain intimately because it will instruct us on what's happening with other medical products as well. according to your answers to us in the record, one of my questions was, what percent of heparin's ingredients are domestically produced versus foreign-produced? fda could not give an exact answer on that. here's what they said. the percent of heparin components produced domestically versus abroad is determined by each manufacturer according to their specifications. and then it says manufacturers of the finished product, heparin to be marketed in the united states do disclose the source of the active pharmaceutical ingredient but you're not necessarily on the ground where that source is being produced and you're saying fda would need to review each application to determine the percentage of foreign-made components in each

finished heparin product available in the u.s. market. so basically the fda doesn't know and it also says there's, please note that the drug applications contain information that is a trade secret. now, as i understand it, heparin is off-patent, am i correct? >> this has been around for a long time. it's a trade secret, commercially confidential or otherwise protected from disclosure to the public under the freedom information act the trade secrets act the privacy -- if something is off-patent, i mean, tell me here why don't the american people have a right to know where the ingredients of heparin come from specifically? what's missing in the law? >> i think, you know, the problem is that heparin and many other products are made in complex ways that have ingredients that come from many

places. the companies take responsibilities for making sure to the degree that they can that the supply chain is safe and intact and we have a responsibility to oversee that process. but in terms of our resources to be in every place where a precursor material is made, it's -- >> is it within your purview to impose user fees on those companies to ensure that product that comes back here is safe or do you need more legislative authority to do that? >> you know, with respect to heparin after the problem arose, there were some fundamental things that needed to be done to shore up the safety of that product. and also that could be applied more broadly. things that involved more intensive screening of the precursor product, more intensive screening of the

manufacturing procedures. more intensive screening of the final product. >> and who's screening is on that? >> we're working with industry. they do provide user fees for the components of work that we do. budget authority pays for many aspects of this company and industry directly through their work takes responsibility for components of it as well. >> thank you. there will be more questions. >> thank you, mr. chairman. and welcome. i apologize for not being here earlier as you may be aware there's a few other things going on this morning. also. but -- and i want to thank you for coming by and visiting. i appreciate that very, very much. last summer the fda released its final drafts guidance 209 on antibiotics used in livestock production to keep animals healthy and products safe.

in the guidance, you laid out plans to phase out the use of growth promotion or production antibiotics as the fda refers to them and increased veterinary oversight on the farms. the production antibiotics fda proposes to eliminate serve two roles to improve the overall health of growing the animal and thus leads to improvement in feed efficiency and growth as a result of improved health and gut integrity. given this final draft guidance, will it directly impact the health of animals and the livelihoods of pork producers and you may be aware in iowa we have six pigs for every human in the state of iowa. i'm really curious as to what sort of outreach has fda done with the producers themselves to get their input? these are farmers who, you know, care for these animals.

they produce a bountiful and safe food supply. and i really think that that type of outreach is extremely important to really understand modern production agriculture. and if you could just talk about that, what kind of outreach or is there a communication that's going on at all? >> well, very much so in our center for veterinary medicine has been deeply engaged in this conversation. it's a very important concern as you know antibiotics are vital for treating illness in disease in humans and animals. it's a vital resource but it's a limited resource in terms of the number of antibiotics available and there are not many new antibiotics in the pipeline. we don't want to be in a position where antibiotic resistance develops where we no longer have tools to treat serious disease in people and animals and that's why we're moving to try to define a framework for their use that is really as judicious and

thoughtful as possible. never denying antibiotics for appropriate treatment when there is an indicated medical need. but reducing use that can contribute to antibiotic resistance and is not medically indicated is not -- for therapeutic purposes. we've been working closely with producers and with industry. have had, you know, a lot of ongoing conversations and a lot of, you know, back and forth. we're trying to move in a voluntary way to accommodate many of these concerns and working with the veterinary community so that we can make sure that antibiotics are administered as appropriate and with appropriate oversight. >> just to clarify, are you saying it's better to wait until

the animals get sick or to have healthy animals all the way along? >> well, we want to have healthy animals but we don't to use our antibiotics in ways that can cause additional furious problems and antibiotic resistance is a very real problem. when there's a therapeutic solution, antibiotics should be used. when it's for growth promotion purposes, that can contribute to antibiotic reversance. -- resistance and in terms of the overall health and well-being of animal and human populations and our ability to have this vital resource of working effective antibiotics we need to move in some new directions. >> i still question whether

you're saying you're not -- in my mind it's better to have a healthy animal to begin with. and just like healthy human beings rather than to wait until you have more of a food risk with diseased animals until you wait after the fact. and it's -- the idea of something like growth promotion or whatever it's just because they're healthy. it's not because they have, you know, hormones or something being fed to them. >> but we know that you can reduce the use of antibiotics in those settings without compromising health of animals. and we need to be judicious in how we use these very vital resources. >> but i think you should give some credit and certainly i would hope that there is input from producers. i mean, they're facing high record input costs.

they're not going to be overusing anything, you know, because their bottom line is very much affected and also its to their economic advantage to have the healthiest animals possible out there. to go spot food system so -- in my mind, it's a concern that's -- don't give the appreciation of the producers and their position that should be, i think, well deserved so anyway. thank you. >> the chair recognizes mr. laurel. >> thank you very much, mr. chairman. good morning, commissioner. >> good morning. >> to all my apologies secretary sebelius was testifying in hhs so -- but i wanted to make it to the hearing this morning. i thank you for the good works

that you all do at the fda. three years ago commissioner the science board reported that the fda was so underfunded that it could not perform its public health mission. congress responded by increasing funding in 2009 and 2010. that progress stalled with this year's continuing resolution. and the house passed h.r. 1 which would cut fda funding by $241 million. i have a series of questions that i'd like answers to. and specific my view as somebody who runs for office every two years that if you can't quantify when you have a, if somebody can't tell you where it's all coming from and where your votes are coming from, you don't have any idea whether or not you're going to win. so it's about the numbers. how would the fda accommodate that kind of cut and how would it address problems identified

by the science board in 2008. specifically in the cuts in h.r. 1 were implemented, would it lead to fewer food safety and medical product inspections? how many? would the cuts impact the amounts of imported food and medical products that gets inspected? how many? given that cuts would have to be enacted in a short amount of time would furlough or reductions in the fda inspection force be necessary? the president's budget closes some of the gap on needs identified by the science posterior. -- board. where does it leave us if we lose ground in 2011 and then fail to fund adequately in fiscal year 2012? what would that do to the agency's ability to perform its mission? what are the risks to public health if fda isn't able to perform its mission?

>> well, we do face, you know, very worrisome situation in terms of the fact that as you recognized, fda's mandates and responsibilities far outstrip our resources for many, many years, many decades, truly, we have been underfunded. underresourced as that science board report pointed out and they called for very significant increases to our budget over a five-year period. we've been very grateful for the resources that we've gotten over the last three years to help build our budget and it has enabled us, i think, to put in place important programs in key areas to protect the health of the public. if we have to face cuts of the magnitude that you're describing, you know, it would be devastating. the size of the cut is equal to the budget of, you know, one of our centers.

of course, we would absorb it across -- >> i'm looking for some specific numbers, madam commissioner, because i think that the import is lost if we do not have the numbers. and again, that's -- you know, i was concerned about funding last year at this time when we spoke about what the senate was going to do with the bill, et cetera. and in order to move in a piece of legislation which is so good and which is so much needed but without the resources to do it, what are the consequences? now, it's not a question of even -- it's a question of the resources for 2012 but we have looming here h.r. 1. i want to know very specifically, as i said, how many few food and medical

product inspections -- what impact on imported food? and imported medical products. and, you know, if you can't answer them today, i really want it laid out very specifically so that it is well-known that what we are playing with here at our risk and we need you to talk about the agency's ability to perform its mission. and what the risks are to public health above all. what the risks are to public health. i don't know if you have any of those numbers here today. >> i can't give you exact numbers in terms of how many fewer inspections. i can tell you that it will be significant. we will be unable to do inspections. domestically and internationally at the levels that we need to be doing. we're already not at the level that we want to be and that we

know that really matters. we will be delayed in our ability to review and approve new medical products that come before us that will have impacts on people who need and are counting on those products. it will have broader impacts on the economy. and the health of the companies making those products, the jobs associated with that, our ability to maintain exports in key areas in our global economic competitiveness. we will not be able to do the work that needs to be done to assure the safety of the blood supply. fundamental things that matter to people every day. so we need to be obviously very thoughtful. we all recognize that we have to tighten budgets.

and, you know, we -- we will -- we will work with congress going forward to examine how we can achieve important cost-savings and the president's proposed budget does contain some significant administrative and contract savings across the agency but we have critical programs, unique programs that are vital to the health and safety of people. >> it's going to be important to this committee and i just outlined some in the food safety area. i think we need to have a catalog and you mentioned a blood supply of what that means. i think it's critically important for this committee to know that in terms of what its actions are going to be and think and i think it's critically important the public to know what is about to befall them if the the legislation comes to the light of day. >> i'll recognize myself to follow-up. back on the food safety modernization act.

we talked about how the budget request for this year is 183 million. i'll acknowledge that i'm new here. i'm still bringing -- i'm still learning. the approach that i had to talk is the exact approach that i took in my business before i got here. probably the same approach that the american consumers have, okay, what are we asked to spend and what do we get for what we spend? 183 million for this year -- do you have a 10-year estimate as to what the enforcement of the food safety modernization act would cost? >> we believe that in order to fully implement the food safety act and its many important mandates and i remember ares that we would need the money that is outlined in the president's fiscal year 2012 budget and we would likely comparable increases over the next couple of years to get us to the overall working budget for this program.

and the businessmen, i think you can appreciate that there are some investments that have a greater return on investment and i think it's really important to underscore that this opportunity that we have to really transform the food safety system in our nation is going to have much more impact than what you're paying up front in terms of those dollars. it is going to reduce costs to the health care system, preventible costs. it's going to reduce unnecessary lost work productivity which is going to be important to our economy. it's going to support the health and growth of critical sectors of our economy, the food industry, enable them to have broader markets here at home, more trust of confidence as

consumers as well as stronger export market. so there's huge return on investment and the costs of these outbreaks of food-borne disease that we know can be prevented are enormous, in the billions. you know, well over 100 billion. >> all right. and i want to continue pursuing it but i think the chairman is back. i'll go back. [laughter] >> mrs. hamburg, we're trying to run this in a manner that that's fastest on everybody. i might want to talk to you about the dietary guidelines and i know you have been involved in this in new york city and so forth. i know that salt is on everybody's drop list. but there are so many articles that take the other side of salt

and i'll submit these for the record. there's five or six of them right here. that count on a fact-based discussion level talk about the sodium intake and, you know, give a counter-side to it and i think somebody at fbi -- while it's okay for an advocacy group to take a position, i don't think that fda should take a position on that until they know -- looked at all the facts. and i'm going to submit these to you and i would like you to get back to me and let me know what the -- what your comments on that are for the record. i also want to switch gears right now and talk about a gao report that came out about a year ago and it was on the office of criminal investigations. and the gist of it was that the office -- the fda office of

criminal investigations operates almost autonomously with the director deciding which cases he or she would report to fda senior management. are you familiar with that report? >> i am. >> have you taken steps to rein that in because what the gao said is that investigations really should come through you and be part of the fda core mission and consistent with it and prioritize rather than have an autonomous group over there doing it their own way. and the gao report also pointed out that their budget had rose by 73% since 1999. and the number of employees have gone up 40%. so withdrew care to comment on that? >> well, we -- we -- that component of the fda does serve

a very important role -- >> well, that's not my question. my question is, have you implemented the gao recommendation or do you disagree with them? >> we reviewed it and took it extremely seriously. a group of individuals followed up in terms of developing a set of actions that should be taken based on that gao report. we are moving forward with that. in addition, we have -- >> where are you right now? can you give me a list of what they are investigating and why they're investigating it? >> you know, i'm not sure i would be allowed why they're investigating. i'd have to -- you know, i'd be happy to if i could. but in terms of the kinds of work that they do, it relates to

some of the important questions that congresswoman emerson was asking about, about the control of counterfeit drugs. >> so you feel like what they're doing is consistent with the core mission even though fda's senior management did not know what they were doing? >> you know, i think that the gao raised a number of very important concerns that we're taking seriously. and as i said, you know, we looked at it and developed a set of action steps. we're also working closely with the department's i.g. because it's all part of a coordinated effort to address a set of enforcement and investigation activities so we're currently in a period both of trying to examine systems and how it works. we have new leadership that's overseeing that component of

fda -- >> what is their new budget. >> i don't know off the top of my head. do you know? we'd have to get that. >> you are aware they have increased 73%? >> that was the gao number. >> all right. here's one of my questions and i'll confess that there's two members of congress who ride bikes to work and i'm one of them. if i google jeff nowitzki. do you know him? >> i don't know him personally. >> who does he answer to? >> he is an employee of that office. >> and so who would be his boss? >> well, his boss would be the head of that office reporting through our -- >> and that is the vacancy right now? the head of that? >> we have an acting head, of course, in that office and then -- >> so he would answer to the acting head?

>> and to the system commissioner that overseas our inspectiat. >> so he's four away from you so to speak? here's my question, and, you know, all the very important issues of food safety and drug safety and everything. if i google nowitzki and i invite you to do it because i did it this morning. i just wanted to confirm. nowitzki and lance armstrong. do you know how many kits come up. >> i don't. >> 116,000. and including going to france to investigate lance armstrong. now, if he's broken the law, then that's a very serious matter but it almost appears to me there's a little adventurism going on. that mr. nowitzki is operating on his own. i would like to know how much has been spent on this investigation and why so much money has been spent?

and is there anybody here who could give me those -- >> i can't give it to you now but i'd be happy to follow up where you. this is also in conjunction with the department of justice. >> but you're aware of this investigation? >> i am. >> and you're aware that i believe millions have been spent lots of times? and i would like to know what priority that is in the food chain because what i'm very concerned about and i hope that i'm proven wrong, but that because it's a celebrity and one great way to make a name for yourself in politics is to bring down a celebrity and certainly people all -- whatever their status is need to follow the law, but it appears that millions of dollars are being spent, lots of employees are involved in this and i'm not sure why so many resources would be put in front of the issues with heparin?

ms. kaptur raised and the issue with oxycontin and so what i want to see from you on this priority list -- and i understand you got to keep some of this quiet but i'd like to know where this is in the priority list and see how many dollars have been spent because i really believe this is one man's tear, maybe a personal issue after somebody else. i'm not sure where the balance is but again, i want to know where it is on the priority list. why it's where it is on the priority list, how many people are in this investigation and how much it has cost the taxpayers? >> okay. i appreciate your concern and i have raised some similar questions in the agency. >> i'm going to shut up in a minute but i want to say to you as a bike rider. it's one of the healthiest things americans can do right now and i know of your personal

interest and health. but this is -- this is an icon who revolutionized bike riding and brought it home to so many americans and again, he's guilty, you know, that's a different manner but i just sense that, you know, this is blown out of proportion in terms of resources put into it. but in terms of public health this is a huge icon that your agency is trying take down. maybe it should. i'm not saying you're wrong on this but what i'm saying is you're really going after somebody whose name is synonymous with health. >> i understand what you're saying. it is an ongoing investigation in the coordination department of justice. i can't speak to the details but we'd be happy to provide you with some of the information that you asked for. i also hope you wear a helmet when you ride your bicycle. >> i do. [laughter] >> i occasionally stop at red lights as well.

[laughter] >> mr. chairman, with a disclosure of how much you ride a bike i'm going to invite you to the greatest bike riding event in the spire world. it's called the sea otter classic out in. i hope some day -- >> as long as they have a slow lane i might be able to make it. >> i must confess i tried to do a bike ride with 17-mile drive but turned around before we completed the whole circuit. i plame my kids for not going to go further. >> but we are a bike-friendly community. thank you. a lot of the discussion has been around cuts and essentially new appropriations. i'd like to focus for a minute on user fees. when we passed the food safety act we had some user fees in there in the house version. it got knocked out in the senate version.

there was the user fee that was an annual registration fee that the food safety enhancement act the annual registration fee for food facilities and i understand that the food facility or the industry supported it and consumer groups supported it. and it was to provide fda with needed additional funding. where is that user fee proposal now? >> you know, i think that at the present time there is an interest in continuing discussions around fees that could help to support the food safety modernization act. you know, as you know, industry, you know, had been supportive or components of industry at least of some kind of registration fee. clearly when you think about food safety it's an issue where both the public and industry have huge investments and

concerns in terms of the outcomes, the benefits. and so it makes sense for it to be a shared responsibility in terms of supporting the programs. we hope that there will be continuing discussions with industry and with congress about user fees. and i think as the president indicated in his budget, you know, we're hoping that in 2013, you know, we'll be -- >> you need -- >> but action before then would be most welcomed -- >> or you need need authority to do that and perhaps we ought to revisit that mr. chairman. you know, my district, when i was on the county board of supervisors and i think in every county in california the county environmental health offices have restaurant inspection fee. every kitchen is required to be inspected. of course, nobody inspects that. you know what? it has an incredible effect in making sure that the food preparation in all our restaurants and food for profit

institutions are done according to health standards and i think -- you know, there doesn't seem to be anybody wanting to repeal that. i think you get -- if you can find a benefit for the fee you better use it. there's another fee the president of the budget anticipates is going to to raise $60 million. it's a voluntary fee. it's called the voluntary fee qualifier program. and i wonder if you could just tell me how that's working? as we talked about earlier, i'm very concerned about a lot of fresh product like grown in mexico and coming to the united states and fresh product grown in the united states and growing to mexico because mexico is the number one trade partner with california and california is the largest ag state in the union. a lot of that trade in mexico is agriculture. and because of our inspection

issues, if that agriculture is delayed, either on the mexican side or the california side -- or the u.s. side, it's just lost. and concerns are all about -- you want to do thorough inspections so you created this sort of fast track program like we did in tourism for folks who want -- who fly regularly all the time. i forgot what the passport is people but who are foreign-born come to this country you pay $50 or more than $500 i forget what the figure is and they get expedited through the customs and the tsp and i wonder if you think this qualified importer program is going to work and work so that those who are spending that money will make sure they get fast tracked? >> you know, i think as we talked about already, you know, the challenge of dealing with all the imported foods is a huge one. and we need to find ways to extend our reach and we need to

find ways to find a risk-based approach and this is one way where we can help where we can reward people with good track records in terms of being able to recognize that they have demonstrated adherence to standards and quality. they don't need the level of inspection, et cetera, that other pervailers and we need a risk strategy. and some strategies that came with the food safety modernization act in order to extend our reach internationally and to utilize third parties.

you know, i think we don't yet have, you know, the foundation of a program in place and it will take a while to build up a program but i think that we would anticipate that it will be a program that will be subscribed and successful and, you know, i would hope we would be able to recover that amount of money but again, this is a request for 2012 so we won't be seeing it immediately. [inaudible] >> my sincere thank you and appreciation for the work that mike taylor is doing in meeting with growers. [laughter] >> i know. i know where you are. i see you hiding back there but

mike, sincerely the effort you made to sit down and listen and show the concern and understanding for a very complex process of trying to ensure leafy green food safety. mr. chairman, almost everything we have produced in this state has some kind of process where you can sterilize it or sanitize it except leafy greens like lettuce. you can't cook it. there's no heat process so you really have to develop all of that food safety spot growing practices. and to be able to have traceability in that and the industry is just -- i mean, the california industry is way ahead of the world. and we're excited about it. remember, they were the ones that came before the committee when roosevelt was chairing and i think shocked us all saying we need to be redding. well, they went out and set out a bunch of tough regulations and they are asking the nation to be regulated like they are and i think it's a good program.

>> i agree with the gentleman and i had an opportunity to be briefed on what the california program was which was voluntary and i thought it was a very positive step. incidentally for what it's worth one of my first jobs was a cook and the way we sanitized the lettuce was -- i hate to say it we soaked it in salt in order to kill the bugs. i'm not sure if that would meet our standards or not. but it was so much better than, you know, salt on lettuce, i might have to give you some some time. [laughter] i will have to give you some some time. >> salt, pepper, oil, and garlic. that is all you need to make it happen. hr 1 dropped the language specifying the level of generic

drug funding in the 2010 bill. there is no report accompanying that bill. there is no idea the level the bill would provide. since it also cuts funding for the fda, which is 40% below 2010 let me ask you about your concern about the impact of the cuts on the procedures of generic drugs. do you perceive -- do you foresee a slow in generic applications? what i am trying to get some idea of so that we know what consequences there are, a sense of how many fewer generic drugs

would be approved under hr 1, =. what can you tell us. >> we have been moving product reviews forward. we beat you about to drugs per business day at the present time. this cut would set us back. it would mean we'd would have the word drugs being approved. >> to you have any idea how many? >> i would prefer to get back to you with exact numbers. it is again one of those issues where we have to not be penny wise and pound foolish. a small cut to that program is going to have repercussions in terms of cost to the health-care

system. i think about 75% of prescriptions in this country today are generic drugs. it is resulting in huge savings. that is a point i want to try to make. we are taking a look at how we want to save money and cut back the cost of health care. now there is also something that i -- you do not have to comment on this. something i wanted to go after, and that is this opportunity that the pharmaceutical companies have were they paid to delay. they pay to delay a generic drugs from coming to the market. they are in essence paying their competitors to do that. if that were not a loud and if we could move generic drugs to the market sooner, on that one specific item that i've mentioned -- if the federal government is purchasing drugs tricare, for medicare, for

medicaid, it is about 8 $3 billion savings. when you think about the savings that can be made if we have generic drugs going to the market, in fact, we can begin to look at how health care costs get reduced which is what we are trying to do. the other piece that i mentioned in terms of the "pay to delay," and that follows on the generic drug peace because $3 billion we could apply to some other effort including reducing the deficit rather than taking the money from food safety modernization or from inspectors were for dealing with some of the other areas that we do. those are the places that we ought to start rather than putting at risk the health and safety of people in this

country. if i cannot quickly to a food modernization peace because it is hard for me to stay away from this area, the legislation calls for the inspection of high risk with every five years and dropping to three years. low-risk would be inspected every seven years and drop to one. based on the information that you currently have, how many food facilities would fall into the high-risk category and how many in the low-risk category? in order to meet the mandate, how much more funding would fta need to reach those inspection frequency is and how many more inspectors would you need to hire? >> first i should have thank you for your leadership on food safety over the years. it has been most appreciated. in terms of your question, let us see if mike taylor -- he says 8000 in the high risk

category. -- 8000 in the high -- >> we are shooting for about 8000 in the high risk. >> low-risk category? >> we do a total of 16,000 inspections. [inaudible] >> when you are looking at high risk, 8000. not a small number for us to have -- not the tools that you need in order to get the job done. >> the mention of the

inspections done by a spate gives me the chance to underscore a point that i did make earlier but i think you were out of the room. another casualty of the cuts in hr1 would potentially be our opportunity to help support the state and local partners and the ability to help strengthen those on the ground at programs that are so important to an integrated food safety program. >> thank you, mr. chairman. >> thank you ms. lore. i wanted to talk to you about the interagency working group on food marketing to children. the proposals that came out in december of 09, it really is something that concerns me.

the potential over reached based on these guidelines that are sitting on the table right now -- and i know we are having a comment. . but under these guidelines that are out there, the foods that would not be allowed to be advertised on television shows in which 50% of the audience are children, are in a butter sandwiches, eggs, granola bars, milt, pretzels, cheerios, brad, -- andrackers, and she's cheese. reason brand, vegetable soup, yogurt, some salad dressing, and againdressingnatural cheese.

and what bothers me -- and the television shows that teenagers watch -- basically college football, fresh prince of bel- air, full house, nascar -- the only thing i can keep up with. news, comedy central, these would not be allowed to advertise on there. does that not strike you as an over reach? particularly because these are allowed to be sold? >> you know, i think that the effort is really geared at trying to make sure that there is an opportunity for information about health products to be as accurate and

as informative and cost possible. certain products are often targeted in ways that are misleading in terms of their nutritional value. and it is the appeal of the sugary sweet and cereal -- >> let me ask you this. it seems like any state has a solution for everything. good old mommy government is here to tell you how to raise our kids. i might want to serve my kids bologna sandwiches. in fact, the sandwiches that committee routinely like eating, two packages would exceed your guidelines and they would not be allowed to advertise. i am going to allow you to come speak next time. he is like a referee in the

background. you cannot see him. but in a way, what does the nanny state wants? let us talk about healthy kids. are you familiar with the family friendly and tv show called "skins"? >> i am not. >> it is not something you necessarily want to 14 year-old watching. yet, you could watch "skins" which is basically a kind of a soft porn, titillating type show. i have not watched it. i have channel surfed through it. but you could watch that show, but you could not buy cheerios -- cheerios would not be allowed to advertise on that. does that not strike you, even for obama government inconsistent? >> from the fda perspective, our

role is to try to get accurate information to consumers so they can make informed choices, hopefully informed sources -- >> is the label not going to do that? >> it is very important to provide that kind of information so people can begin to see what is in their foods. >> i know you wanted so that when i take my wife out for a romantic valentine's dinner we have to read to the content of the food before we can 0 -- order our fish and estate. i am not going to let you steal my romantic evening. i do not know where the nanny state is planning on stopping. it is one thing after the other that you plan to control grid i want to invite you to look at a review of the show "skins." we are saying that, fine, you can watch this. freedom of speech. >> i am not here knocking

"skins," but i think it is ironic that sure rios cannot be advertised on it because that might hurt our teenagers. not that they are running around in skimpy little close doing naughty things. [laughter] if i have not drawn up a little advertising and interest in the show -- >> we have to run because we have to call for votes. i think we are going to go into what is advertised in television, let us go after prescription drugs that are driving the airwaves. by the time they get to the disclaimers they are going to tell you you are going to die. i do not know why anyone would buy it, but they seem to be affected. it is just over low. it is a piece of. -- it is abusive. i wonder if you could get some information to this committee on a number of tests on pesticides

for fresh produce at the border. you do not have to give me that right now, but if you could get to committee. at the time it has taken the agency to return the results of those tests. i want to look at the number, time, and then i want to know if there are enough resources to analyze and report these tests. this is where speed is essential, if there are any gaps in being able to provide that speed i would like to know about them. lastly, i would like to read something. i want to get that on the record in writing. i would like for you to be aware on the issue regarding import procedures for release notices for cocoa beans. it has come to my attention that several of the cocoa processing industry are facing time delays

and additional financial burden at u.s. ports because of the need to clean the product at the ports, not at the processing facility. i do not even know all of the facts, but i will submit it to you and -- >> thank you. i will have to admit that i am not up to speed on cocoa bean imports. we will get back to you with information on that. and on the other it is very important. i which is that what you said about time being essential with the testing of fresh produce coming into this country, it is an area where we have a huge opportunity to apply better site so we can have on site diagnostics to give us answers quickly and to be able to move products more swiftly which matters to companies that it matters to the quality of the produce and it matters to people who want those foods on their plates. >> when you think about it, when we move from a fast-food society to this so-called "sl;ow'food"

or "fresh food", we are going to move fast to make sure that this low food is what we claim to be. thank you. >> i was just complaining to the very distinguished democrat clarke that i think you guys took out our timekeeper back here on the television. you might have another two minutes if you want. >> i am finished, mr. chairman. we have to go. >> we appreciate it. we are going to have to run on the. we will have a lot of questions for the record. but i do want to say that you are extremely important agency to every single household in america. we all take a lot of pride in your work, we all have opinions of what you are doing right and wrong. we went to work to this process with you. we appreciate what you are doing. while the hearing is ending, our

discussions will not. thank you, this committee hearing is adjourned. >> thank you. would [inaudible conversations]

[inaudible conversations]

from washington journal representative kevin yoder a freshman member of congress talks about the federal budget and his role on the budget and spending task force of the republicans group. this is about 40 minutes. to a >> host: let me introduce you to freshman kevin yeutter republican of kansas and member of the appropriations committeet first visit to the washington journal understand. thanks for being here.alk a we arebo going to talk about the federal budget and job creationt strategy steps for the house republicans. "the wall street journal" is reporting a three-week bill on spending will be offered.

can you tell us more? guest: house leadership is working on putting together a package of spending reductions that will keep the government open while keeping their commitment to reducing the size of the federal budget. about a week and have ago, we passed a two-week extension that will expire on march 18. we are working on trying to come up with another extension. the end goal is to come up with an extension until the end of the fiscal year, which ends in september. in the meantime, as we try to negotiate what that bill will look like with the senate, we need to keep the government operating. our commitment is to reduce spending while doing that. i think our bill will continue to cut billions in spending while keeping the government functioning. host: how important is it for you to keep the government functioning? guest: i do not think the americans sent us here to shut down government. they sent us here to solve problems and reduce the size of the budget.

i think americans in both parties from coast to coast want people in washington to lead and solve problems and reduce the size of the federal budget. i do not think shutting down the budget is the message that the americans are sending to us. they want us to try to solve problems. host: i want to show a brief clip from the senate floor. majority leader harry reid yesterday. let's listen. >> i can only speak for my caucus. we accept the lessons of yesterday's vote. we know we will have to make a sacrifice to reach consensus. we are willing to do that. republicans have to be willing to move their position also. host: i have a number of questions. as a freshman member of the house, what has your lesson than about the bicameral legislature and when things move to the senate floor? guest: we are two for two.

the senate is struggling in finding a consensus. the senate and house operate differently. the republicans are a minority in washington with the senate run by the democrats as well as the executive branch. we know we will not be able to push something through without the senate in gauging and doing their part. we are all watched fall. we are doing everything we can to try to advocate for what we think they should do. ultimately, the senate will have to leave. at this point, it does not seem like they have a concise plan. host: i want to give you the phone numbers so you can join in on the conversation about funding the government for this year. also, there's work going on on the 2012 federal budget. you can reach us by e-mail and

twitter. lots of ways to get involved if you would like to ask questions of kevin yoder of kansas. he also suggested that republicans will need to compromise. how willing are you to compromise? guest: we do not think the legislation the house passed has gone far enough. we are running a trip to sit -- we're running a deficit of $1.5 trillion. the bill would reduce spending by about $5 billion. the rest of the year, we have to figure that out. we think reductions need to be greater than what the house has passed. we're not trying to force a government shutdown. we're not trying to put people in a situation where there are so many poison pills that they cannot accept the legislation. the same time, we just had an election. there's a new republican majority in the house precisely because we ran on the platform

of change in the course of business in this town and reducing spending. we feel we need to stick to those principles. we understand we have to cooperate. host: papers are filled with some of the consequences of cutting the federal budget stories. here are two. "the washington times." of course, this extends to municipalities, as well. they're talking about the sudden loss of block grants. they have said it is irresponsible, vicious, and hateful attack on the middle class that they would be cut and cut so quickly. this is "the new york times" this morning, talking about the consequences of cutting head start. this is an editorial in "the washington times" about ethanol

subsidies. when it comes from talking globally to talking about specific programs, where are your bottom lines? what kind of programs are you willing to cut? how are you approaching this philosophically? guest: it's very difficult when you start talking about every program and the impact to individuals. my heart goes out to americans held by programs that we've had to eliminate or reduce. i do not think we relish the idea in any of the situations that we are having to make these discussions. we are borrowing over 40 cents out of every $1 we spend in washington. it is not responsible. ever -- americans across the country have to do more with less. why can't the government? the folks in washington keep spending more and more. there are hundreds and hundreds of programs across this town that do things for americans that provide a service to them

that is beneficial. we cannot afford all of them. that's the challenge. we are taking the tough task of finding reductions. i do not believe we can leave parts of the budget and approached. i think everything has to be on the table. host: does that include social security, medicare, and medicate? we would never talk about any reform affecting 55 or older. we have to be careful about the debate. seniors who are at the age of retirement or receiving benefits or social security, they can rest assured that their benefits are protected. for the folks that are 55 years and under, we will have to enter a national dialogue. do we want to have dramatically higher taxes? i think that is where we are right now. we are engaged in a dialogue with the american people.

we are not trying to ram it through congress. we are doing town hall meetings and discussing the problems that we face and are asking for input from americans. the ideas are not going to come from a roomful of bureaucrats. host: the age has been addressed in the past. why are they off the table right now? guest: i think adjusting benefits for folks currently receiving them is not something we want to do in washington. we think folks 55 years and older who have determined that have paid in four decades into the system -- which do not think it is fair to start throwing them off of benefits. we want to figure out a long- term plan for those folks in their 20s, 30s, and 40's and figure out a system that works for us going forward. the younger generation has to figure this out. we will, with some solutions

that provide for a balanced budget that will create prosperity that we all want. host: i want to get to some calls. let's begin with st. louis, missouri. jerry, you are on the air. good morning to you. what are you thinking as you are watching this debate? caller: i have heard everything but i have not heard them wanting to give up anything. [unintelligible] host: ok. members of congress and how they are situated. guest: i think members of congress could give up just like anyone else. when i was in the legislature for eight yea le n to reduce our own pay. i think congress should step up and do those similar things. i think we should sacrifice and

lead by example. i would be supportive of legislation or an amendment that would come to the floor. one of the things we first did was reduce our budget for our office. we cut spending on expenses in our own office. that was a start. i agree that was a start. >> >> host: if we roll back the bush tax cuts our debt would go down by 60% overnight? >> guest: well, this is really the essence of the national debate. we have folks on one side of the debate that believe we should spend more money in washington to create jobs back home. where i come from in kansas, we're not getting stimulus dollars that are creating all these jobs in our local communities. what creates jobs for small business owners and for folks who need help is helping out small businesses so that they can have the ability to create,

innovate, create entrepreneurial programs. that's where jobs are created at home. so i don't believe that sending more tax revenue to washington will creating jobs to get this economy going again. i think it will have the opposite effect as taxes go up i think -- the other thing is that the history shows the more money we send to washington the more they spend and i think americans may be more comfortable sending more money to washington if they knew it was going to pay down the debt and create fiscal insolvency. what would happen washington would spend more money and the debt would continue to grow. so what we have in the city is not a revenue program. what we have a revan problem. -- revenue problem. we have a spending problem and many of these programs are growing far faster than inflation. we can't spend more money than we have i can't understand as a new washington why washington doesn't get that. the culture in this town that believes they can spend how much they want regardless of what

they have and americans are fed up for that attitude. . >> host: our next call comes from cape cod. phil an independent here. >> caller: i haven't heard this representative say anything about corporate america chopping out of america as well. everybody else has to chop out. why are we giving these subsidies to these oil companies? why are we giving these corporate tax breaks? they keep saying that don't tax the wealthy because they create jobs. the last i understood, there aren't any jobs and they had these tax breaks for the past 8 years or two years. you keep saying the mom and pop stores to save them taxes, you know, to give them a tax break to hire more people, but your small business policy doesn't apply to them. it applies to the corporations.

the ones that the own or two three owners that's millionaires okay. and they got like maybe four or five employees. so -- i mean, you're talking on both sides of your mouth -- you want us to talk the hit as the middle class but corporate america and upper echelon don't want to pay their fair share so where's the fair and balance there? >> guest: well, i think there's a culture of overspending in washington and what we want to create an efficient and effective government that spends dollars wisely. and so the challenge isn't why aren't we taxing enough. the challenge is why are we spending so much. i understand the caller's concern and that jobs aren't being created in the private sector but the answer isn't to create more jobs in the public sector. we've already done that. the federal government is much larger than what it needs to be has. what we need to stimulate job growth back home and i don't believe greater taxes on small businesses or any businesses back home are going to encourage them to create jobs. many of the policies that come

out of the washington over the past few years, the health care proposal, the dodd-frank financial services bill all the new rules and regulations that are coming to hit small businesses, and businesses alike have created a very hostile climate in this country for folks to create jobs and so people are shipping jobs overseas. they're not keeping them at home. we have -- we have one of the highest corporate income tax rates in the world and so my dream for this country is that we would have the best place in the world to create jobs, start a business and grow it and build the prosperity of this country and i don't believe that raising taxes is going to recreate that prosperity that americans want to have. and so i just think -- i disagree with the caller. i think the wrong direction to take our country is raising taxes and creating more jobs in washington. >> host: we are trying with our limited international resources just to to keep on the earthquake and tsunami story. and associated press has just announced and msnbc has tweeted

and that's what we're going to show you on the screen right now that japan is now issuing an evacuation order to thousands of residents in that country near a nuclear power plant. and certainly we'll to keep on this as it gets closer to the hawaiian shore, the tsunami resulting from this, keep an eye on breaking news and we'll watch the news and come back to us on this friday morning. this is a big day for people to follow what's going on in the world. okay. jobs, i want to stay with that for a minute. i pulled the baltimore sign because it's typical of what's going on all the country. maryland job gains prove slim. home sales rising but it turns out unemployment is not -- it's john 71,000 in january. we looked at your own unemployment rate in kansas and kansas city, kansas city itself 8%. the state of kansas 7.4 compared to a national average of 8.9. what's happening with jobs in your district? >> guest: well, the job numbers

that you're referring to, unemployment is lower than it is nationally. we have an economy that's probably stronger locally than it is nationally. . >> host: and why is that? >> guest: well, you know, we try to keep -- we try to keep tax rates low and a low regulatory environment in kansas and foster innovation from small businesses. we try to be very welcoming to capital and growth. one of the things we're focusing on in kansas city is bio science. we're trying to keep it a regional for -- >> host: but are the government subsidies supporting that? >> guest: in terms of the -- >> >> host: of the bio science. >> guest: there's research comes from the federal government. . >> host: well, that's an investment that's working for you. >> guest: we're working these reductions at home. i voted to reduce research subsidies. i voted to reduce a lot of these things because i can't in good conscience continue to borrow 40 cents --.

>> host: even if it has an impact on jobs. >> guest: even if it has federal money from my constituents from washington at home. we believe those projects and products back home can be run better locally. the state involvement or local involvement we just think when you go to washington -- when we send our money to washington we just get less money back. it has to go through the bureaucracy. but the other issue at home is, it's not just the unemployment rate. there are small business owners, there are folks all across the community that don't show up on those numbers who aren't taking paychecks. who are struggling to survive and what they're not asking for is another washington bailout. what they're not asking for is greater washington taxes. what they want is stability. they want washington to stop flooding them with regulations. a great example is the 1099 requirement that we recently passed in the house to repeal the requirement that every business who spends more than $600 in transactions has to fill out irs paperwork. it's a bureaucratic nightmare and so we're trying to do the

things in washington to help those businesses back home create jobs. . >> host: next call for congressman kevin yoder of kansas. >> caller: good morning. thank you for c-span. i have to say if we were not in two wars and if the bush administration wouldn't have hired the tsa, homeland security, gave so much money to the defense department, we would be in a whole lot better shape than what we're in. and certain things you're asking us to make concessions. we make concessions every day. but not one person in the senate or in the house are saying anything about their benefits. i am tired of the working people, men and women, taking this from people like you. you did not answer the man's question in wisconsin.

when are you going to make concessions? get us out of these two wars that cost us billions every three days? that's our problem. thank you. i'll take my comment off the air. . >> host: thank you, becky? >> guest: well, i think first of all, i don't spend my time focusing on which president or which congress made the mistakes. i think we can certainly go through and redebate a lot of these decisions. i think as a new member of congress and that's one of the reasons we sent a lot of new voices this is one of the biggest classes in history. of new members because americans in both parties, independents across this country, are tired of seeing washington spend more money than it has and that goes for domestic programs and defense programs and so there are reductions. the pentagon said there are reductions that could be made. i believe that, you know, as the

president works to remove troops from overseas we'll start reducing cost. i mean, i understand the caller's premise. reductions need to be made everywhere including defense and including our activities overseas in the middle east. we're spending more money than we have and so i don't think we can just approach one part of the budget to solve this problem. and as i answered the other caller's question i believe that we do need -- i think congress should consider reducing its own benefits. i would support an amendment or a bill that was on the floor that we do that. and so i'm happy to do that and i think that's the type of leadership we need to display. we did that in the kansas legislature. reduced our own salaries. frankly that would be something we could do here and i'd certainly support that. . >> host: next call virginia beach. >> caller: i have see the federal government go like topsy. when the republicans came out,

all of them that ran said they would cut spending levels back to 2008 for all 800, 900 federal agencies. right now they just seem to be nibbling around the edges. well, prior to every federal agency above baseline got an increase every year of 4 to 7%. bush came in and cut it back to 4%. in 2006 when the democrats took over, they raised it again 10 to 15%. in 2009 obama increased it to another 28% that's why that debt clock is ticking over and over again. the federal agency 800 or 900 of them are living right now on an average of 20 to 30% automatic increase. and the republicans promised to cut it back to 2008 levels. we're all going to have to suffer pain. why don't you cut it to 2008

levels right now instead of nibbling around the edges? >> well, i believe that the bill we passed in the house cut many or most of those programs back to the 2008 level to get to that $100 billion mark that republicans pledged they would reduce in spending. and we're in the process right now where the senate is making a very minimal set of reductions. i think they're looking at about $6 billion and our reductions would cut about $61 billion off of current spending. those dollars are real. they're necessary to make reductions. and i agree with the caller. we are just nibbling around the edges and that's why when we're negotiating around the senate who doesn't want to make reductions and the house who wants to make some starting reductions we're really just moving deck chairs around the titanic. we need to get serious and we need true government reform. i'm very ready to lead and be part of that and it's not part of forcing sacrifice. what it is about spending the money we have and not borrowing 40 cents out of every dollar.

americans all across the country they get it and they're small businesses and their family budget -- they've had to cut back. in washington they demand more and more and more. i'm looking on the appropriations committee at new budget requests, new submissions that request thousands of new employees. the folks in washington just don't get it. and we're here as new members in this country to wake them up and let them know that americans are fed up with the new spending. many of us lay the fault at the feet of both parties. this is less about party and more about fiscal sanity and fiscal responsibility. >> host: back to the tsunami story. we are waiting in hawaii right now. it's the prediction of tsunami of 6.5 feet would be reaching the shores at 3:07 eastern time which is 3:07 hawaii time which

is 8:07 right around now and we're waiting for the impact of the waves. it's suggested that the national weather service the alarm started sounding overnight for the people in the coastal zones and it looks like the largest wave will be 2 meters more than 6 feet. 6 feet and all residents in the tsunami inundation zone. we're waiting for this big earthquake result of the tsunami to hit u.s. shores momentarily. and we'll keep you posted as the news comes out of there. port huron, michigan, we have about 10 minutes as we talk about the budget tsunami. i'll mix my metaphors. henry is a democrat and henry you are on the air. go ahead, please >> caller: kevin, i'd like for, if you really are serious about

doing something about the budget, first of all, i'd like for you to take some leadership and introduce a bill that would, of course, cut or make sure that that congress pays for more of their medical, make sure that congress takes a pay cut. introduce a bill, tell eric cantor to introduce a bill that will cut subsidies to all states, for every dollar that each state sends to the federal government, they should get a dollar back and there are no states that should have any kind of advantage over another state. you republicans don't like government. then cut all of your government contracts. do not accept any more. than your state sends in federal dollars. go to the 400 richest people who

have more than 155 million people in this country in wealth some and ask them to pay their fair share of the taxes. if you are not just trying to raise the misery index and make president obama look bad and position yourself for 2011 then you'll start doing some serious legislation that cuts everyone across-the-board especially the ceos and the thieves that got us into this position with the bonds that they sold and tranches and securitization. >> host: okay, henry. thanks. we got your call. >> guest: i disagree with the premise of the call. i'm not antigovernment. we're not looking to destroy government. what we are is looking to find an effective, and efficient use of government resources and

right now there's a tremendous amount of government waste and inefficiency in this town. programs continue to agree and grow without results growing and growing. americans know that sending more money to washington isn't going to create jobs back home where any of these dollars are going home i don't think attacking ceos, attacking individuals across this country and sending more money to washington, that's not the answer. we have a real debate in this country. we're going to have to decide, do we want a country that borrows and spends in taxes and regulates and is that the answer to prosperity? or do we believe we want to create a free enterprise system of economic freedom for individuals to grow and create jobs at home? and usually the answer in washington is, for every problem, it's a new regulation or a new government program. the gao came out this last week with hundreds of duplications in which we have -- i think it was 80-some programs in washington just to deal with economic

development. and 100 programs to deal with accountability. whatever it is we have so many programs and the answer in washington has always been let's borrow from future generations. let's attack folks back home by raising taxes and i think americans are tired of that. i think what they want to see us do is balance our budget and live within our means. and if -- one of the things we have to do that we don't -- we don't reduce spending now and get this budget in line in 10 years, 15 years, 20 years we're in a huge crisis. so it's close to crisis today. we're going to be bankrupt soon. i think the "wall street journal" reported we borrowed $200 billion a year in interest today and in 10 years we're going to borrow almost a trillion dollars in interest. that is a shipping of resources to overseas and foreign countries that are loaning us this money we have to decide what kind of country we want. does this america look like?

and i believe the best country is to create prosperity through a system that allows individuals to work and agree and create jobs. at home. a lot of system that's full of government spending, government waste, government bureaucracy, government taxation, government regulation. i don't think that's the america we want to build. and so the idea that we want to go home and attack folks and raise taxes and send more money to washington, that's just not going to fix the problem. and i believe we can get there as long as we work together. >> we are out of time. i know you've already returned to your alma mater to talk to students there about life in washington. can you give our c-span viewers here who watch the congress your overriding impression of what it's like to be in the house after your first two months here? >> guest: well, it's -- it's an amazing experience. the problems that we're facing are very challenging. but we have a new group of folks that are very optimistic.

like i said they haven't beaten the optimism out of me. i still believe we can build this country and restore the principles that have made us so prosperous and such a beacon of hope around the world. i take this job very seriously. it's very humbling and one the american people are count on us to get the job done and i get up with the purpose of getting to the capital and getting to work and restore the principles and values. >> next, more on u.s. foreign aid with congresswoman nita lowelly. the ranking member of state and foreign operations was a guest on this morning's "washington journal." this is 35 minutes. >> host: thanks for being here this morning. >> guest: my pressure. >> host: wow, we got a lot going on. i'm going to start with libz just because the secretary was talking about it. again, leaders in europe are meeting, france is pushing for a no-fly zone. what are your thoughts about the

u.s. involvement level? how big should it be. >> guest: it's clear after discussing it in depth after speaking with secretary clinton that the united states is actively involved in strategy sessions and discussions, with the international community. the united states cannot act independently. and people may say no-fly zone. they may say -- they may come up with all kinds of actions but number one there are implications as secretary gates said to everyone of the proposal that unless we act with the international community, i don't think it will be effective for us to take any action by ourselves. we've spoken out publicly. it is absolutely abhorrent that

a leader should be shooting his own people and killing his own people. and i hope there can be some consensus from the international community. . >> host: we were anticipating that the big story out of that region today would be saudi arabia and we heard there might be some government shots fired into the crowds as they were assembling tonight. that's all been eclipsed by japan and the earthquake followed by the tsunami there. you were telling me on the break you've just come back from japan. >> guest: in came back from japan as part of a congressional exchange program. they are a good ally. they have been an active member of the six-party talks in the region which is so very essential. and this is just devastating. and when you viewed the reports after you just met so many members and their leadership and

you go in their homes and you had such in-depth discussions for three or four days, to see this happening is just devastating. japan was probably one of the most organized places i have ever visited. the streets are clean. the people are polite. there is a plan for everything that has to happen. and i know that they have been preparing for a possible earthquake or a tsunami for a long time. they were preparing for it. and they're responding when the tall buildings are shaking. and people are losing their lives. hopefully, the lives lost will be kept to a minimum because of the preparation. >> host: yeah this is also a domestic story we told you earlier that the waves are beginning to reach the coastline in hawaii and it is scheduled to do so right now as we're speaking. and a viewer just tweeted to us

that oregon's north coastal areas are being evacuated. twitter is great for all the local reporting on this. so weird said this viewer. i want to get back why we're here of foreign aid spending>> guest: when something of that magnitude hit two years ago, the united states as well gets involved. we send resources we send aid. how do we appointing that federally for these unexpected natural disasters. >> guest: first of all, i want to make it clear it all your viewers that our foreign aid budget is 1% of our total expenditures. and i agree with many of the new members of congress that we should be evaluating every program, cutting out waste, fraud and abuse and certainly there are programs that may not be as efficient as others. and even in the foreign aid program, when i was the chair

and now ranking member, we worked together on a bipartisan way to make sure there's appropriate oversight. we're spending billions of dollars to afghanistan. spending billions of dollars to pakistan, for example, the total budget, though, is only 1%. and when there were stories -- i happened to get people on my block about the $3 billion that was on a pallet going from dubai to afghanistan and i immediately held up that money until we came to a conclusion and an understanding as to where that money came from. and where it was going. so we provide excellent oversight on our foreign aid budget and we still can do more because we have found problems with it but it's minuscule. and when you're seeing in japan who do not get foreign aid, but

in disasters which happened in haiti, we can respond and we did respond. number one, it's in the interest of the national security of the united states to respond to disasters. we know that when communities, countries are in turmoil, this can cause tremendous action on the part of terrorist organizations such as al-qaeda recruiting people who don't have food who don't have clothing who don't have clean water. so i think it's important to remember 1% of the budget as president bush said, our national security depends on defense, diplomacy and development and we have to think all this working together. >> one set of numbers on the screen and get your telephone calls. we'll be here just to the top of the hour. we're out early today paw the house will be in a half hour from now.

just to show you a difference of the two parties on thinking on related programs. the president for this fiscal year is requesting a 56.7 billion and the house $45 billion. now, you've been saying it's short-sighted and make the case for people. >> guest: okay. number one i want to repeat again that the united states of america depends on the defense dollars. no one ever wants to cut defense out so those are being cut too but not in proportion to foreign aid. defense diplomacy and development. turmoil, terrorists, they're on a very fer till soil when they are in communities lacking the basic essentials of life. so it's in our interest. secondly, we are a moral society. and there are many people who

support foreign aid because they understand it's important to help other people. whether it is hiv aids, whether it is malaria, whether it's providing drinking water. i've been to some countries where family planning is not adequate and women who can barely support their children are having a ninth and a tenth child. so it's in the interest of the united states for national security, it's in the interest of the united states because we are a society that believes we have to be helpful to others. >> host: one last article and then to your cars. this is from the financial times this morning because the treasury secretary has been on capital also trying to make the case for maintaining funding levels for key foreign aid programs, here's the headline. i apologize for the state of this article. fears over funding threat to u.s. influence. robin, in washington from the "washington times" today. init